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Alendronate and/or Parathyroid Hormone for Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000400
First Posted: November 4, 1999
Last Update Posted: December 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robert M. Neer, MD, Massachusetts General Hospital
  Purpose
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.

Condition Intervention Phase
Osteoporosis Drug: Human parathyroid hormone [hPTH-(1-34)] Drug: alendronate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Formation-Resorption Coupling and Osteoporosis

Resource links provided by NLM:


Further study details as provided by Robert M. Neer, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • change in spine bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]

Secondary Outcome Measures:
  • change in hip bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in forearm bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in total body bone mineral [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in femoral shaft bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in serum PINP [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum osteocalcin [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum NTX [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalcemia [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalciuria [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of symptoms [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]

Enrollment: 176
Study Start Date: August 1999
Study Completion Date: June 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH
Human parathyroid hormone [hPTH-(1-34)]
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
Other Name: teriparatide
Active Comparator: ALN
Alendronate
Drug: alendronate
70 mg/week by oral route
Other Name: Fosamax
Experimental: PTH+ALN
Human parathyroid hormone [hPTH-(1-34)] plus alendronate
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
Other Name: teriparatide
Drug: alendronate
70 mg/week by oral route
Other Name: Fosamax

Detailed Description:

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lumbar spine or hip BMD T-score less than or equal to minus 2.0
  • Postmenopausal at least 5 years
  • Fully ambulatory
  • Able to give informed consent

Exclusion Criteria:

  • No concurrent illnesses that cause bone loss
  • No recent drug treatment for osteoporosis
  • No recent fracture
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000400


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Robert M. Neer, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert M. Neer, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00000400     History of Changes
Other Study ID Numbers: P50 AR44855 NIAMS-023
P50AR044855 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Robert M. Neer, MD, Massachusetts General Hospital:
Osteoporosis
Bone formation
Bone resorption
Parathyroid hormone (PTH)
Postmenopause

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones
Alendronate
Teriparatide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents